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Mind-Body Training for Hand Rehabilitation

NCT ID: NCT02459847

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-05-31

Brief Summary

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The objectives of this pilot study are to: (1) evaluate acute effects of biofeedback and mindfulness training on pain, anxiety, and stress during a hand therapy visit and (2) gain understanding of patient perceptions, preferences, and experiences with mind-body interventions.

Detailed Description

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Each year more than $5.7 billion is spent on outpatient therapy, which is projected to grow 6% annually over the next decade. Subsequently, healthcare reform is mandating more efficient, high-quality care to control spending. Thus, the long-term goal of this work is to develop an integrative health intervention for hand therapy that improves efficiency, enhances outcomes and reduce costs. Biofeedback and mindfulness training are two mind-body interventions that can increase patient engagement and self-efficacy. No research has investigated the integration of these mind-body interventions into treatment for hand therapy patients. This pilot research will explore the acute effects of these techniques in hand therapy patients. This study utilizes a repeated-measures crossover design with 20 participants to explore the effects of mindfulness training and the dynamic biofeedback with sonographic imaging on acute pain, anxiety, and stress. Additionally, the study will evaluate hand therapy patient preferences and perceptions of mind-body techniques. This patient-centered, clinical translational work will provide valuable feasibility data regarding the direct, acute effects of mind-body interventions to inform the development and further study of an integrative hand rehabilitation approach. This responds to a need for best practices for maximizing the mind-body connection and the call to investigate innovative uses of mindfulness to enhance patient outcomes.

Conditions

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Arm Injuries Hand Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness

Two sessions, each lasting 60-minutes total. The first session involves standard hand therapy care for the entire session. The second session begins with the participant listening to a 19-minute audio-recorded body scan (i.e., mindfulness training), followed by standard care.

Group Type EXPERIMENTAL

Mindfulness Training

Intervention Type BEHAVIORAL

Standard Care

Intervention Type OTHER

Biofeedback

Two sessions, each lasting 60-minutes total. The first session involves standard hand therapy care for the entire session. The second session begins with the participant receiving 20 minutes of visual biofeedback training using sonographic imaging (i.e., sonographic biofeedback), followed by standard care.

Group Type EXPERIMENTAL

Sonographic Biofeedback

Intervention Type BEHAVIORAL

Standard Care

Intervention Type OTHER

Interventions

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Mindfulness Training

Intervention Type BEHAVIORAL

Sonographic Biofeedback

Intervention Type BEHAVIORAL

Standard Care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Referral to USC Keck Hospital Hand Clinic
* Upper extremity pathology resulting in decreased hand use
* Pain with activity greater than 4 out of 10
* Scheduled to attend at least 2 therapy sessions per week
* Speak and read English
* Able to independently read and respond to questionnaires

Exclusion Criteria

* Cast or open wounds in the distal upper extremity
* Bilateral upper extremity pathology involvement
* Significant visual or hearing deficit
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Shawn Roll

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shawn C Roll, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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USC Keck Hospital Hand Clinic

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Hardison ME, Roll SC. Mindfulness Interventions in Physical Rehabilitation: A Scoping Review. Am J Occup Ther. 2016 May-Jun;70(3):7003290030p1-9. doi: 10.5014/ajot.2016.018069.

Reference Type BACKGROUND
PMID: 27089297 (View on PubMed)

Roll SC, Hardison ME, Vigen C, Black DS. Mindful Body Scans and Sonographic Biofeedback as Preparatory Activities to Address Patient Psychological States in Hand Therapy: A Pilot Study. Hand Ther. 2020 Sep;25(3):98-106. doi: 10.1177/1758998320930752. Epub 2020 Jun 9.

Reference Type RESULT
PMID: 33244321 (View on PubMed)

Takata SC, Hardison ME, Roll SC. Fostering Holistic Hand Therapy: Emergent Themes of Client Experiences of Mind-Body Interventions. OTJR (Thorofare N J). 2020 Apr;40(2):122-130. doi: 10.1177/1539449219888835. Epub 2019 Nov 25.

Reference Type RESULT
PMID: 31762376 (View on PubMed)

Other Identifiers

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Founders Grant

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HS-14-00320

Identifier Type: -

Identifier Source: org_study_id